At Treatment Week 24, all participants with detectable HCV-RNA will be discontinued from treatment and followed for a Post Treatment period of 24 weeks. Participants with undetectable HCV-RNA values at Treatment Week 24 will be randomized to either:

Group A: an additional 24 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 48 weeks of treatment.

Group B: an additional 48 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 72 weeks of treatment.

Study Population:

300 HIV infected adults with chronic hepatitis C infection who have not been treated previously with interferon therapy.

5.2.11 Reconfirmation and documentation that all sexually active female patients of childbearing potential are practicing adequate contraception (intrauterine device, oral contraceptives, progesterone implanted rods [Norplant], medroxyprogesterone acetate [Depo-Provera], surgical sterilization, barrier method [diaphragm + spermicide], or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for 6 months after discontinuation of therapy. Female patients must not breast feed during the treatment period and for 6 months after discontinuation of therapy. A urine pregnancy test obtained at entry prior to the initiation of treatment must be negative.

5.2.12 Reconfirmation and documentation that sexually active male patients are practicing acceptable methods of contraception (vasectomy, use of a condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 6 months after discontinuation of therapy.

5.2.13 Anyone at high risk of coronary artery disease should have a stress test performed prior to entry. This would include, but not be limited to, patients over age 55 who have a history of ischemia or who have a significant history of hypertension, diabetes mellitus, obesity, smoking and/or strong family history of coronary artery disease. Patients with evidence of ischemia on resting or stress EKG, or a history of an arrhythmia, angina or a myocardial infarction within 12 months must be excluded.

5.2.14 Although recommended, liver biopsy is not required for study entry. However, if a liver biopsy has been obtained, within three years of the initial screening visit, the pathology report will be collected with other study data.

Exclusion Criteria:

5.3 Exclusion Criteria

Patients meeting any of the following criteria are not eligible for this trial:

5.3.1 Inability or unwillingness to provide written informed consent specific to this protocol or unwillingness to participate in and comply with the study.

5.3.2 Previous therapy with interferon alfa.

5.3.3 Women with ongoing pregnancy or breast-feeding.

5.3.4 Male partners of women who are pregnant.

5.3.5 Hypersensitivity to interferon or ribavirin.

5.3.6 Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy.

5.3.7 Any other causes for chronic liver disease other than chronic hepatitis C.

5.3.8 Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia.

5.3.9 Any known preexisting medical condition that could interfere with a patient’s participation in the protocol including: CNS trauma or active seizure disorders requiring medication; poorly controlled diabetes mellitus; serious pulmonary disease; immunologically-mediated diseases; gout; or any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.

5.3.10 Patients with evidence of ischemia upon stress testing (required for patients at risk of or with a history of coronary artery disease, ECG evidence of ischemia, an arrhythmia, cardiac failure, coronary surgery, uncontrolled hypertension, angina or a myocardial infarction within 12 months).

5.3.13 History of major organ transplantation with an existing functional graft (including Bone Marrow Transplants)

5.3.14 History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) £6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.

5.3.16 Coadministration of didanosine (DDI, dideoxyadenosine 5’-triphosphate) and ribavirin is not recommended.

5.3.17 Evidence of alcohol and/or drug abuse within one year of entry. Patients on methadone programs are not excluded.

5.3.18 Inability to abstain from alcohol throughout the entire course of treatment and follow-up.

5.3.19 History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.

5.3.20 History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215891